A Cohort Study on Screening and Follow-up of High-risk Population of PDAC Based on EUS
1 other identifier
observational
900
0 countries
N/A
Brief Summary
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer. Study design: This is a real world, multicenter, prospective, observational cohort study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 9, 2024
April 1, 2024
1.5 years
November 10, 2022
April 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with T1 PDAC
Patients found with early stage PDAC, which means tumor size \< 2cm.
5 years
Number of Participants with no clear pancreas lesions
Patients found with no clear pancreas lesions during 5 years follow-up.
5 years
Secondary Outcomes (5)
Number of Participants with other stages of PDAC
5 years
Number of Participants with IPMN
5 years
Number of Participants with chronic pancreatitis
5 years
Number of Participants with autoimmune pancreatitis
5 years
Number of Participants with other pancreas diseases
5 years
Study Arms (3)
Solid mass
Patients with solid mass of pancreas during pancreas MR examination.
Cystic lesions
Patients with cystic lesions or expansion of MPD during pancreas MR examination.
No clear focus
Patients with no clear focus during pancreas MR examination.
Interventions
Use endoscopic ultrasound to examine the pancreatic lesions.
If solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis.
Eligibility Criteria
Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
You may qualify if:
- From the beginning of the study to the end of the study, the 18-80 year old patients who were admitted to Peking Union Medical College Hospital and related research centers and who met the high-risk population of pancreatic cancer understood and were willing to participate in the study and signed the informed consent form.
- In this study, the high-risk population of pancreatic cancer is defined as patients who meet any of the following conditions:
- A. Patients with previous history of pancreatitis (acute or chronic).
- B. Patients with pancreatic cancer related genetic background, including immediate relatives with a family history of pancreatic cancer. Or genetic syndrome related to pancreatic cancer. \[including hereditary breast cancer ovarian cancer syndrome (HBOCS), carney complex (CNC), familial adenomatous polyps (FAP), hereditary diffuse gastric cancer syndrome (HDGC), juvenile polyposis (JPS), cutaneous malignant melanoma (CMM), hereditary papillary renal cell carcinoma (HPRCC) and Lynch syndrome\]
- C. Patients with continuous or progressive increase of CA19-9 and CEA.
- D. Patients with potential malignant pancreatic tumors, including mucinous cystic tumor (MCN) and intraductal papillary myxoma of the pancreas (IPMN).
- E. Newly diagnosed patients with diabetes (within 3 years after diagnosis of diabetes).
- F. Other patients who are considered as having high risk factors for pancreatic cancer.
You may not qualify if:
- A. Those who are not suitable for endoscopic examination, including but not limited to: poor general condition, serious heart and lung disease, and difficult to tolerate the examination; coagulation disorders; platelets \<50 × 10\^9/L；those who are not suitable for endoscopic examination after interview by an endoscopic physician.
- B. The patient or family member could not understand the conditions and objectives of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Beijing Hospitalcollaborator
- Tongji Hospitalcollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
Biospecimen
Baseline sample includes 20ml blood sample, 1 dental plaque sample and 1 stool sample. Follow-up samples include 10mL blood sample, duodenal fluid samples collected during EUS examination and remaining samples of pancreatic puncture tissue and/or cyst fluid during EUS.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xi Wu, M.D.
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Shengyu Zhang, M.D.
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Yuheng Zhang, MD candidate
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 18, 2022
Study Start
December 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
April 9, 2024
Record last verified: 2024-04